The present invention is directed to the field of medical diagnoses, and, more specifically, diagnoses performed by detecting reactions in blood caused by the presence of foreign substances therein.
I refer to this test as the "MRT" Test.
The MRT Test relates to the field of hypersensitivity reactions observed in humans and animals. These reactions can be due to contact with offending substances such as medications, environmental chemicals, foods, carcinogens, food additives, etc.
The MRT Test is an in-vitro assay which indirectly detects the release of mediators in whole blood after it is mixed with a test substance. When a patient's blood reacts with the test substance, intracellular fluids are released, causing the liquid portion of blood to increase, while the total volume of the solids present in the blood decreases. These reactions may be caused by various immunologic and non-immunologic mechanisms.
Accordingly, it is an objective of this invention to provide an in-vitro method which will identify reactions caused by various test substances.
It is also an objective of this invention to identify the volumetric differences in the level of plasma in non-treated blood vs. the level of plasma in treated blood.
It is a further objective of this invention to use this new laboratory method as a unique way to solve the problem of identifying maladies which are otherwise difficult to diagnose.
About blood:
Blood is a liquid that circulates throughout the body using the vascular system and is in contact with practically every cell in the body. Blood delivers oxygen, food and other essential elements to all of our cells. Approximately 50% of blood is a fluid called serum (or plasma). It is a complex mixture of water, various proteins, carbohydrates, lipids, and electrolytes. Small amounts of other substances such as vitamins. Minerals, and hormones are also found in blood. The other 50% of blood is comprised of solids such as erythrocytes (red blood cells: RBC), leukocytes (white blood cells: WBC), and thrombocytes (Platelets).
The white blood cells are a significant part of our body's immune system. The immune system is highly complex and intricate in its design and is responsible for defending against foreign invaders such as bacteria, viruses, and other pathogens. The science of immunology incorporates the study of resistance to infections and the rejections of so called "foreign substances".
Gell and Coombs in their 1962 book, Clinical Aspects of Immunology, have identified various immune mediated hypersensitivity reactions and categorized them as Types I-IV, based upon the mechanics of the reaction. Types I, II. and III are identified as antibody mediated and the fourth one is described as cell mediated.
It is understood that Type I is the most widely occurring hypersensitivity reaction. It involves Mast cells and basophils, which bind IgE through their Fc receptors. After encountering the antigen, the antibody induces degranulation (the destruction of the exterior wall of the cell) and release of mediators.
Type II reactions involve the binding of antigen and antibody on the surface of a cell, generally resulting in the destruction of the cell. As is the case in a Type I reaction, the final outcome of this reaction generates the release of cellular contents (including the release of the mediators).
Type III reactions address the interactions of cells with complexes. Immune complexes, when deposited on tissue, cause complement activation, which in turn attracts polymorphonuclear leukocytes ("polymorphs"). As their normal response, the polymorphs will attempt phagocytosis on the complexes, but in many instances the complexes will be trapped by the tissue, blocking phagocytosis. As a natural course, polymorphs will release inflammatory mediators.
Type IV reactions involve sensitized T-lymphocytes. After the second contact with a specific antigen. T cells release lymphokines, which produces an inflammatory response, and in turn attracts mediator-releasing macrophages.
This is an accepted theory, which generally explains the partial release of cytoplasm and mediators into the blood stream, or upon tissue as a result of such reactions. As these reactions occur, the volumetric level of the plasma will change.
As observed under the microscope, there are two possible reactions triggered by offending substances;
a. release of liquid (substance, cytoplasm and mediators) from cells, causing decrease in solids/liquid volumetric ratio in blood; or PA1 b. consumption of liquids, causing increase of solids/liquid ratio in blood.
It appears that at any time human blood can react one way or the other However, it was also observed that usually only one type of reaction takes place at a time.
It is contemplated that similar phenomena takes place by reason of contact with chemical substances such as gases (aerosols, pesticides, gases, cigarette fumes), paints, perfumes, oils, gas, thinners, air fresheners, food additives, drugs, and many other substances.
There is very little scientific explanation why humans and animals react to the above named substances. Some theories suggest a classic allergic reaction, while others state that lack of specific enzymes, helping to neutralize foreign substances, are the reason for those reactions.
In summary, reactions caused by immune, toxic, pharmacological and other mechanisms may cause the release of mediators into the blood stream.
Current methods of diagnosis exist for measuring the degree of reaction a patient's blood may have with a suspected allergen, by measuring the size and number of blood cells in a patient's blood. Such tests are described in my prior U.S. Pat. Nos. 4,614,722; 4,788,155; and 5,147,785, the disclosures of which are herein incorporated by reference. In essence, these patented tests operate by comparing the number and size of cells in a patient's blood before and after exposure to a foreign substance. If there is a significant cellular shift after exposure, then a positive reaction is determined.
These tests, while a significant improvement in the art at the time they were made, have a drawback, in that they do not well measure small differences in cell sizes caused by the described cellular reactions.
Currently, no tests are known which may test for the reaction blood cells have to foreign substances resulting in changes in plasma volume independent of changes in cell size distributions.